Surgical prep solution applicator system and methods

ABSTRACT

Systems and methods for applying or dispensing surgical prep solution are disclosed. The applicator system includes a spreader element and a container of surgical prep solution. The spreader element includes a body with an orifice covered by a pad. The orifice is in fluid communication with a passage through an elongated stem connected to the body. The container may be collapsible with only limited recovery. The spreader element may include a receptacle for receiving the container.

RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 09/561,556 filed on Apr. 28, 2000 and titledSURGICAL PREP SOLUTION DISPENSER WITH ATTACHABLE CONTAINER, which is acontinuation-in-part of U.S. patent application Ser. No. 09/541,348filed on Apr. 3, 2000 and titled SURGICAL PREP SOLUTION DISPENSER WITHATTACHABLE CONTAINER, both of which are hereby incorporated herein byreference in their entirety.

TECHNICAL FIELD

[0002] This invention relates to liquid applicators having particularutility in the field of antiseptic skin surface preparation. Moreparticularly, this invention relates to articles and methods useful inapplying pre-operative surgical scrubs or paints to skin.

BACKGROUND

[0003] Antiseptic preparation of patient's skin for surgeryconventionally includes a 3-10 minute scrubbing of the affected areawith a soap solution followed by the application of a water-solubleantiseptic paint solution. These solutions are generally applied withsaturated sponges attached to a blade or held with forceps. Thesesponges are often saturated by soaking them in open pans of solution.Sometimes, sponges with attached handles are provided in a plastic pouchcontaining enough liquid to saturate the sponges.

[0004] While inexpensive, these techniques are messy and offer littlecontrol over inadvertent dripping of the solution into areas where it isundesired. Because many of the available solutions contain activeingredients such as alcohol and iodine, good control over theapplication has long been desirable.

[0005] Devices have been developed in an attempt to prevent the drippingof solution associated with these early techniques, and to reduce thetime required for application of the antiseptic solution. In particular,the DURAPREP products commercially available from 3M Company of St.Paul, Minn. have enjoyed commercial success by providing substantiallydrip-free, convenient application. U.S. Pat. No. 4,925,327 describes aliquid applicator that incorporates a rigid, porous metering insert toregulate the flow rate of liquid disposed between the applicator handleand a foam sponge covering a major orifice of the handle. The liquid tobe dispensed is contained in a rupturable reservoir removably affixed atthe other major orifice of the handle.

[0006] U.S. Pat. No. 5,658,084 further discloses a liquid applicator inwhich the liquid is contained in a frangible ampoule inside the body ofthe applicator. This ampoule is supported and protected by a deformableelement that prevents unintentional breakage of the ampoule from impactsduring storage and handling before use. The applicator is actuated bypushing at least a portion of the frangible ampoule through an aperturein the deformable element and into contact with a means for breaking theampoule.

[0007] Such ampoules are made of glass, in spite of the fact that sealedglass ampoules are relatively expensive. Many clinicians prefer to applythe prep in full aseptic attire (including sterile surgical gloves) and,therefore, it is important that the applicator that will be touched bythose gloves be provided in a sterile condition. And since, for example,iodine based solutions decompose with exposure to gamma irradiation,manufacturers turn to gas sterilization with ethylene oxide gas tosterilize the outer surface of the container. Iodine solutions can formtoxic by products such as iodohydrin (2-iodoethanol) when exposed toethylene oxide sterilization, so they must be protected from exposure tothis sterilant. Glass is a good barrier to agents such as ethyleneoxide, unlike many other commonly used medical packaging materials, andso has been the material of choice for containing the prep solutions inspite of its cost.

[0008] While these described products have provided considerableadvances, they are complex to manufacture, placing them beyond the meansof some health care consumers. The art could still benefit from anapplicator that could provide convenient, substantially drip-freedispensing of surgical preps at a lower cost.

SUMMARY OF THE INVENTION

[0009] The present invention provides a systems and methods for applyingor dispensing surgical prep solution. Among the potential advantages ofthe systems and methods of the invention are the ability to dispensesurgical prep solution substantially drip-free.

[0010] The applicator system includes a spreader element and a containerof surgical prep solution. The spreader element preferably includes abody with at least one orifice covered by a pad. The orifice is in fluidcommunication with a passage through an elongated stem connected to thebody.

[0011] The passage connects to a spout on the container when thesurgical prep solution is to be dispensed. It may be preferred to anglethe stem relative to the pad and, further, to provide a stem that islong enough to ensure that, if the applicator is used by a clinicianwith sterile gloved hands, the gloves do not come close to contactingthe patient's skin so as to contaminate the gloves and violate aseptictechnique.

[0012] As used in connection with the present invention, “surgical prepsolution” includes skin and/or mucosa antiseptic compositions that maybe useful for preparing the skin for other medical procedures such asthe introduction of catheters, inoculations, etc. In some instances,surgical prep solutions used in connection with the invention may befilm-forming when, e.g., applied to human or animal skin.

[0013] Surgical prep solutions used in connection with the presentinvention may include one or more of a variety of human skin-compatibleantimicrobial agents. Examples of some suitable antimicrobial agentsinclude, but are not limited to, chlorhexidine, triclosan, octenidene,quaternary ammonium functional surfactants, etc. It may be preferred,but not required, that the surgical prep solution include iodine orchlorhexidine in its composition. It may further be preferred that thesurgical prep solution include alcohol in its composition. One suitablesurgical prep solution may be, e.g., DURAPREP surgical prep solutionavailable from 3M, St. Paul, Minn.

[0014] When using low viscosity surgical prep solutions (which may alsobe of relatively low surface tension), it may be preferred to provide aflow restrictor between the container and the pad. The flow restrictorpartially restricts the flow of surgical prep solution from thecontainer to the spreader element to enhance uniform filling of the padwith solution and reduce or prevent dripping. The flow restrictor maytake a variety of forms as described below.

[0015] The container may, for example, be provided in a tube resemblinga toothpaste tube. The container holds the surgical prep solution andincludes a spout adapted to attach to the stem. It may be preferred thatthe container is rigid enough to act as a handle for the applicatorsystem in combination with the stem.

[0016] The container is collapsible and compression of the containercauses the surgical prep solution to flow from the container to the padwhen the container is attached to the spreader element. The collapsiblecontainer preferably does not recover significantly when depressed.

[0017] This property of being collapsible without significant recoverycan assist with the avoidance of dripping. Many commercially availablecontainers are resilient and recover substantially all of their originalvolume after compression. In many instances this results in refilling ofthe container with air. If a recovered container is used, the cliniciancould be inspired to compress the container one or more additionaltimes. The additional compression pushes air down the stem, which canforce the surgical prep solution out of the pad, resulting inundesirable dripping. In addition to dripping, the air may also causethe surgical prep solution to foam.

[0018] As used in connection with the present invention, the collapsiblecontainers provide an original volume when filled with surgical prepsolution and before dispensing of the surgical prep solution. Afterdispensing of the surgical prep solution, the compressed containers canbe described as having a collapsed volume less than the original volume.The collapsible containers of the present invention preferably recoverabout 50% or less (more preferably about 25% or less) of the differencebetween the original volume and the collapsed volume within 30 secondsof dispensing a majority of the surgical prep solution in the container.

[0019] It may be further preferred that the container be impermeable toethylene oxide gas, which allows the container to be sterilized byconventional ethylene oxide sterilizers without allowing ethylene oxideto penetrate the container. Penetration of ethylene oxide into thecontainer has the potential to create toxic products within the surgicalprep solution. This may be especially true with surgical prep solutionsincluding iodine, in which 2-iodoethanol (iodohydrin) can be formed withexposure to ethylene oxide.

[0020] Preferred impermeable containers do not allow more than 100 ppmethylene oxide into the container during exposure to ethylene oxide gasduring sterilization, preferably less than 50 ppm, more preferably lessthan 25, and most preferably less than 10 ppm. Ideally, the container ismanufactured of materials that provide a complete barrier to ethyleneoxide gas penetration (less than 1 ppm, which is the current detectionlimit).

[0021] Suitable containers for use in the present invention maypreferably retain surgical prep solution even when aged at 50° C. for 28days with no more than, e.g., a 2 percent net weight loss. This can beespecially difficult with hydroalcoholic surgical prep solutions. Onepotentially suitable material for the containers may be, e.g.,polymer/aluminum foil laminates.

[0022] The container also includes a spout through which the surgicalprep solution is delivered from the container to the spreader element.Although spouts in the form of threaded male members are disclosed inconnection with the illustrative embodiments, it should be understoodthat spouts used in connection with the containers may alternativelytake any suitable form that can cooperate with the spreader element todeliver surgical prep solution from the container to the pad.

[0023] The spout may preferably include a container seal formed over itsopening. More preferably, the container includes a sealed spout that isimpermeable to ethylene oxide, e.g., a polyolefin/foil laminate seal.The seal may preferably be opened as the container is engaged with thespreader element.

[0024] In preferred embodiments of the present invention, the system isunvented when the container is properly connected to the spreadingelement. As used herein, unvented means that the only opening into thefluid path is through the orifice in the spreader element body. With anunvented system, compression of the container causes the surgical prepsolution to rapidly travel through the passage and into the pad. Thiscan be faster and more convenient than waiting for gravity to move thesurgical prep solution into the pad as in prior art vented applicators.Preferred unvented systems require compression of the container todispense the surgical prep solution in sufficient amounts to wet thepad.

[0025] It may also be preferred that at least the exterior surfaces ofthe spreader element and the container be sterile such that theapplicator system can be used in an aseptic manner to apply the surgicalprep solution. This may necessarily require that the spreader elementand container be provided in a sterile package.

[0026] In some instances, it may be preferred that the spreader elementinclude a receptacle at the proximal end of the stem that

[0027] In one aspect, the present invention provides an applicatorsystem for surgical prep solution, the system including a spreaderelement and a collapsible container of surgical prep solution. Thespreader element includes a body with an orifice; a pad attached to thebody over the orifice; a stem comprising a distal end attached to thebody and a passage extending between the distal end of the stem and aproximal end of the stem, wherein the passage is in fluid communicationwith the orifice at the distal end of the stem. The collapsiblecontainer includes surgical prep solution and a spout adapted to attachto the proximal end of the stem, wherein the surgical prep solution canbe delivered to the passage for delivery to the pad. The collapsiblecontainer has an original volume and a collapsed volume after dispensingof the surgical prep solution. The collapsible container recovers about50% or less of the difference between the original volume and thecollapsed volume within 30 seconds of dispensing of a majority of thesurgical prep solution.

[0028] In another aspect, the present invention provides method ofapplying surgical prep solution by providing a spreader elementincluding a body having an orifice; a pad attached to the body over theorifice; a stem having a distal end attached to the body and a passageextending between the distal end of the stem and a proximal end of thestem, wherein the passage is in fluid communication with the orifice atthe distal end of the stem. The method further includes providingsurgical prep solution in a collapsible container; attaching thecollapsible container to the proximal end of the stem, wherein thesurgical prep solution is in fluid communication with the passage of thestem; and dispensing the surgical prep solution into the passage bycompressing the collapsible container, wherein the collapsible containerhas an original volume and a collapsed volume after dispensing of thesurgical prep solution, and further wherein the collapsible containerrecovers about 50% or less of the difference between the original volumeand the collapsed volume within 30 seconds of dispensing a majority ofthe surgical prep solution.

[0029] In another aspect, the present invention provides a method ofmanufacturing an applicator system for surgical prep solution, themethod including providing a spreader element that includes a bodyhaving an orifice; a pad attached to the body over the orifice; and astem comprising a distal end attached to the body and a passageextending between the distal end of the stem and a proximal end of thestem, wherein the passage is in fluid communication with the orifice atthe distal end of the stem. The method further includes providing acollapsible container including surgical prep solution and a spoutadapted to attach to the stem of the spreader element, wherein thesurgical prep solution can be delivered to the passage for delivery tothe pad. The collapsible container has an original volume and acollapsed volume after dispensing of the surgical prep solution, and thecollapsible container recovers about 50% or less of a difference betweenthe original volume and the collapsed volume within 30 seconds ofdispensing of a majority of the surgical prep solution.

[0030] In another aspect, the present invention provides an applicatorsystem for surgical prep solution. The system includes a spreaderelement and a collapsible container attached to the spreader element.The spreader element includes a body with an orifice and a pad attachedto the body over the orifice. The spreader element also includes a stemwith a distal end attached to the body and a passage extending betweenthe distal end of the stem and a proximal end of the stem, wherein thepassage is in fluid communication with the orifice at the distal end ofthe stem. The collapsible container retains surgical prep solutiontherein (until dispensed) and has an original volume and a collapsedvolume after dispensing of the surgical prep solution, and furtherwherein the collapsible container recovers about 50% or less of adifference between the original volume and the collapsed volume within30 seconds of dispensing a majority of the surgical prep solution. Thecontainer may also include a container seal retaining the surgical prepsolution within the collapsible container.

[0031] In another aspect, the present invention provides an applicatorsystem for surgical prep solution, the system including a containerretaining surgical prep solution therein and a spreader element. Thespreader element includes a body having an orifice and a pad attached tothe body over the orifice. The spreader element also includes a stemwith a distal end attached to the body and a passage extending betweenthe distal end of the stem and a proximal end of the stem, wherein thepassage is in fluid communication with the orifice at the distal end ofthe stem. Further, the spreader element includes a receptacle at theproximal end of the stem, the receptacle extending around at least aportion of a circumference of the container when the container isattached to the spreader element.

[0032] These and other features and advantages of the present inventionare described below in connection with various illustrative embodimentsof the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0033]FIG. 1 is a perspective view of the elements of the applicatoraccording to the present invention;

[0034]FIG. 2 is a perspective view of the elements of FIG. 1 in anassembled condition;

[0035]FIG. 3 is a detailed bottom view of the body of the spreaderelement with the foam pad removed;

[0036]FIG. 4 is a bottom view of an alternate embodiment of the body ofthe spreader element with the foam pad removed;

[0037]FIG. 5 is a perspective view of an alternate embodiment of anapplicator system, with the container depicted in broken lines to exposeall of the spreader element;

[0038]FIG. 6 is an exploded view of an alternative spreader element;

[0039]FIG. 7 is a perspective view of the spreader element of theapplicator of FIGS. 5 and 6 in which the container is removed toillustrate the proximal end of the stem;

[0040]FIG. 8 is a cross-sectional view of a spout with container sealfor use on a container of the present invention; and

[0041]FIG. 9 is a cross-sectional view of a portion of another spreaderelement of the invention.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE INVENTION

[0042] Referring now to FIGS. 1-3, an illustrative embodiment of oneapplicator system according to the present invention is depicted. Theapplicator system 10 includes a spreader element 12 and a container 14.The container 14 is not attached to the spreader element 12 and isfilled with surgical prep solution used to, e.g., prepare a patient forvarious medical or surgical procedures.

[0043] The spreader element 12 includes a body 16 and a stem 18. Thestem 18 includes a passage 20 formed therethrough, the passage 20 beingin fluid communication with an orifice 21 formed in the body 16.

[0044] The container 14 is depicted in FIG. 1 with an optional cap 22covering an optional spout on the container 14. Connection of thecontainer 14 to the spreader element 12 involves removing the cap 22 (ifprovided with the container 14) and attaching the spout of the container14 to the proximal end of the stem 18 as depicted in FIG. 2.

[0045] The spout on the container 14 may preferably include threads thatengage threads 24 formed in the passage 20 at the proximal end of thestem 18. It will be readily apparent that there are a number ofalternative mechanical expedients used to connect the spout of thecontainer 14 to the spreader element 12 such that the surgical prepsolution does not leak at the junction between the container 14 and thespreader element 12, e.g., bayonet fittings, snap fittings, taperedpress fittings, etc.

[0046] Referring to FIG. 2, a perspective view of the elements of FIG. 1in an assembled condition is illustrated. The cap 22 has been removed,and the container 14 has been fitted onto the stem 18 so that thesurgical prep solution in the container 14 can pass through the passage20 to wet the pad 26.

[0047] It should be noted that although the spreader element 12 andcontainer 14 may be provided disassembled as illustrated in FIG. 1, itmay be preferred to provide the two components as assembled in FIG. 2.If so provided, it may also be preferred that the container 14 be sealedsuch that any surgical prep solution is retained within the container 14such that the surgical prep solution is prevented from reaching the pad26. The spreader element 12 and container 14 may be connected by athreaded connection (see, e.g., FIGS. 7 & 8 below) in which a portion ofthe complementary threads are engaged to retain the two components in anassembled state. When so provided, additional rotation of the container14 relative to the spreader element 12 may open a seal to allow deliveryof the surgical prep solution to the pad 26.

[0048] In another potential alternative, the container 14 may beprovided with a bayonet connection, snap-lock connection, etc. to thespreader element 12 such that rotation and/or translational movement ofthe container 14 along the longitudinal axis of the stem 18 cause thecontainer 14 to open, thereby allowing the surgical prep solution tomove into the pad 26. Other connections that achieve the desired resultof retaining the components in an assembled state while preventingdelivery of the surgical prep solution to the pad 26.

[0049] The stem 18 may preferably be elongated such that the handle isat least 2.5 cm, more preferably at least 5 cm, and most preferably atleast 6 cm from the top of the body 16 of the spreader element 12. Inthis manner, a clinician applying the surgical prep solution can do sowith a reduced risk of contaminating his gloved hands by contact withthe patient. In other applications, an elongated stem may advantageouslyprovide access to body orifices, e.g., the vagina.

[0050] The spreader element 12 also includes a pad 26 attached to thebody 16 such that the pad 26 covers the orifice 21 of the body 16. Thepad 26 may be formed of any suitable material or materials that willabsorb the surgical prep solution and allow it to be delivered to thepatient's skin. Exemplary pads may be manufactured of materials thatinclude, but are not limited to, open cell foams (e.g., open cellpolyurethane foams), fibrous materials (woven or nonwoven), etc.

[0051] Surgical prep solutions used in connection with the presentinvention may have very low viscosities, e.g., 100 cps or less, possibly50 cps or less, and even 20 cps or less (measured at 23° C.).Furthermore, many preferred surgical prep solutions contain eitheralcohol (e.g., 2 propanol, n-propanol, or ethanol) or surfactants. As aresult, the surface tension of the surgical prep solutions used inconnection with the present invention may be relatively low, e.g., 50dyne/cm or less, possibly 40 dyne/cm or less, and even 30 dyne/cm orless.

[0052] This combination of low viscosity and low surface tension canmake filling the pad 26 without dripping a difficult challenge. For thisreason, in preferred embodiments the spreader element 12 preferablyincludes a flow restrictor. In one embodiment, the flow restrictor maybe provided in the form of the entire passage 20 may be of a relativelysmall cross-sectional area. For example, in one preferred embodimentused with a hydroalcoholic surgical prep solution, a circularcylindrical passage 20 having a diameter of about 2 mm and a length ofabout 55 mm may provide a suitable flow restrictor.

[0053] In another manner of characterizing a flow restrictor in terms ofthe dimensions of passage 20, it may be preferred that the passage havea ratio of length of the passage between the distal and proximal ends ofthe stem to a minimum cross-sectional dimension of the passage of about20:1 or more. This definition would include passages with uniformcross-sectional areas along their length or those in which only aportion of the passage has a reduced cross-sectional area.

[0054] Alternatively, the flow restrictor may be provided by an orifice21 that is small enough to restrict flow from the passage 20. In anotheralternative, the flow restrictor may be provided in the spout of thecontainer 14, such that only a limited flow of surgical prep solutionfrom the container 14 is provided as the container 14 is compressed.

[0055] Referring now to FIG. 3, a detailed bottom view of the body 16 ofthe spreader element 12 with the pad 26 removed is depicted. The body 16includes distribution channels 28 in fluid communication with theorifice 21. In the depicted embodiment, the distribution channels 28radiate outward from the orifice 21, although this is not a requirementof the invention. It may be preferred to provide only a single orifice21 in the body 16. Alternatively, more than one orifice may be providedin the body 16.

[0056] The pad 26 may preferably is sealed around the outer periphery ofthe body 16 of the spreader element 12. The pad seal formed between thepad 26 and the body 16 is preferably leak-proof to force the surgicalprep solution to travel through the pad 26 rather than pass between thepad 26 and the body 16, where it is more likely to drip from thespreader element 12. Suitable pad seals may include, e.g., but are notlimited to, hot melt, pressure sensitive, and curable adhesives; RFweldable gaskets, ultrasonic welding, thermal welding, etc.

[0057] Referring now to FIG. 4, a detailed bottom view of an alternateembodiment of the body 16 of the spreader element 12, with the foam pad26 removed, is illustrated. The view is similar to that of FIG. 3, butin this embodiment a liquid impermeable adhesive coated film patch 30has been adhered to the underside of the body 16 so that the surgicalprep solution must travel along at least some of at least one of thedistribution channels 28 before it can begin to soak into the pad 26.Alternatively, the film patch 30 can be placed on or adhere to the paddirectly in front of passage 20 of FIG. 3. With a 5×5 cm open-celledpolyurethane pad, a 1.75 cm diameter patch has proven useful. This patchis thus about 35 percent of the width of the pad. Patches that are 25-50percent of the pad width may be considered suitable.

[0058] Referring now to FIG. 5, a perspective view of an alternateembodiment of the applicator system 110 is illustrated. The applicatorsystem 110 includes a spreader element 112 and a container 114 thatholds a surgical prep solution. The spreader element 112 includes a body116 and a stem 118.

[0059] In the depicted embodiment, the stem 118 includes a receptacle132 at its proximal end that is shaped to receive the container 114.Conveniently, the receptacle 132 may form, e.g., a flange that assistsin aligning the container 114 with the stem 118 for convenientattachment. For example, when the spout of the container 114 and thestem 118 include complementary threads, the receptacle 132 may assistthe user in properly aligning the threads on the opposing elements. Inaddition, the receptacle 132 may impart additional rigidity thatfacilitates application of the surgical prep solution.

[0060] The receptacle 132 may preferably extend around at least aportion of the circumference of the container 114 for a portion of thelength of the container 114 past any spout used to connect the containerto the spreader element 112 (up to and including completely encirclingthe container 114). It may, however, be preferred that the receptacle132 extend about only a portion of the circumference of the container114 in a manner as illustrated in FIG. 5. Limiting circumferentialcoverage of the container 114 by the receptacle 132 may be advantageousby, for example, providing the user with a better view while making theconnection between the container 114 and the spreader element 112.Another reason to limit the circumferential coverage of the receptacle132 is to allow the user to prompt an additional flow of the surgicalprep solution from the container 114 into the pad 126 with a slightapplication of thumb pressure to the exposed surface of the container114 opposite the receptacle 132.

[0061] Referring now to FIG. 6, an exploded view of the spreader element112 is depicted and includes an optional metering layer 140 between thepad 126 and the body 116. The optional metering layer 140 may provide anadditional flow restrictor or an alternative flow restrictor between thepad 126 and container 114 to restrict flow of the surgical prepsolution.

[0062] One potential metering layer 140 may be provided in the form of aporous film that includes a pattern of frusto-conical openings formedtherethrough, such that the openings are smaller on one side of the filmand larger on the opposite side of the film. Suitable orientation of themetering layer may provide the desired amount of flow restriction. Onepotential product having this structure replicated in a polyethylenefilm is available from Tredegar Corporation (Richmond, Va.) under thetradename VISIPORE (Product No. S-6010025).

[0063] Also depicted in FIG. 6 is a seal ridge 150 used in forming a padseal in the form of weld between the body 116 and the pad 126 in oneembodiment of the present invention. The seal ridge 150 extends aboutthe periphery of the body 116 and is preferably continuous such that acontinuous pad seal can be formed. The seal ridge 150 may preferably beformed of a thermoplastic material. In some embodiments, substantiallythe entire spreader element 112 may be manufactured of a thermoplasticmaterial. Preferably, the pad seal can be formed through the meteringfabric 140 (if the metering fabric 140 is present).

[0064] Regardless, by providing at least the seal ridge 150 of athermoplastic material, the seal ridge 150 may be at least partiallymelted, followed by application of the pad 126 to the softened sealridge 150 under pressure until the seal ridge 150 cools. The result is afluid tight pad seal in the form of a weld between the body 116 and thepad 126. The seal ridge 150 may, for example, be heated by conductionfrom a release-coated heated platen, hot air, etc.

[0065] Referring now to FIG. 7, a perspective view of the spreaderelement 112 of is depicted with the container removed to expose theproximal end of the stem 118. In this view the passage 120 forconducting the surgical prep solution from the container through thestem 118 and into the pad 126 can be seen.

[0066]FIG. 8 illustrates one spout 170 that may be used on a containerin connection with the present invention. The spout 170 also includes anoptional container seal 180 to prevent leakage of the surgical prepsolution 102 from the spout 170 (and associated container) beforeconnection to the spreader element. The container seal 180 may be, e.g.,an adhesive or heat bonded foil laminate seal or other suitableconstruction that prevents unwanted leakage of the surgical prepsolution 102. It may be preferred that the seal 180 also provide aneffective barrier to the penetration of ethylene oxide gas duringsterilization.

[0067] Threads 124 may preferably be provided in the proximal end of thestem 118 for attaching the spout 170 to the spreader element 112. Thethreads 124 preferably engage complementary threads 172 on the spout170. Other attachment techniques and structures may be used in place ofthreads as noted above.

[0068] Turning back to FIG. 7, a piercing element 160 in the form of anannular die is provided in the passage 120 of spreader element 112. Thepiercing element 160 may be provided to, e.g., open a seal on thecontainer such as the container seal 180, thereby allowing the surgicalprep solution 102 to move into the passage 120 and to the pad 126.Preferred annular dies may include one or more protrusions or notches onthe cutting edge of the die to initiate tearing of any seal. Thedepicted piercing element 160 is in the form of an annular die locatedwithin the passage 120. As a result, as the spout 170 is threaded ontothe stem 118, the piercing element 160 opens the container seal 180.

[0069] It may be preferred that the various components are sized andshaped so that the threads are almost fully engaged prior to opening ofthe container seal 180. This may reduce or eliminate leakage at thejunction between the spout 170 and the stem 118 even if the container isnot held upright during assembly. While the illustrated embodiment isshown with an annular die as a piercing element 160, other arrangementswhich pierce the seal may be used such as a projection, which may becentered or off-center within the passage 120. Further, the piercingelement (in whatever form) may be formed as an integral part of the stem118, or it may be provided as a separate insert assembled into the stemafter the stem 118 is manufactured.

[0070]FIG. 9 depicts an additional optional feature of the presentinvention in the form of a plenum 219 formed between the pad 226 and thebody 216. The plenum 219 receives surgical prep solution traveling alongthe passage 220 in stem 218 through the orifice 221 (over which the pad226 is attached). The plenum 219 may help to evenly distribute thesurgical prep solution to the pad 226.

EXAMPLES

[0071] Advantages of the invention are illustrated by the followingexamples. However, the particular materials and amounts thereof recitedin these examples, as well as other conditions and details, are to beinterpreted to apply broadly in the art and should not be construed tounduly limit the invention.

Example 1

[0072] A body generally as depicted in the drawing was machined from twopieces of Delrin plastic such that the stem extended away from the restof the body at an angle of about 45 degrees. The main plane of the bodywas approximately 5 cm by 5 cm, and the stem was about 4.8 cm in length.The stem was threaded to accept complementary threads on the containerelement. Distribution channels were machined into the bottom surface ofthe body by end milling 0.29 cm diameter grooves in the body in such away as to create a eight individual paths from the center of the bodynearly to its edge. The artisan will perceive that injection moldingwill be a preferred method of fabricating the body in quantity, and thatother polymers, such as polyolefins, will be suited to suchmanufacturing.

[0073] A foam pad, commercially available from Illbruck, Minneapolis,Minn. and identified as P 90 Z Beige Clickable foam pad was adhesivelyattached to the body using a hot melt adhesive. A bead of hot meltadhesive was applied to the perimeter of the foam pad and the pad andDelrin plastic connector were brought into contact with one another forabout 30 seconds.

[0074] A polymer/foil/polymer three-layer tube, where the foil isaluminum and the polymer is polyethylene, available from ExpacCorporation, Montvale, N.J. was used as the container element to contain26 ml of DURAPREP surgical prep solution (including isopropanol/water,acrylate terpolymer, iodine and sodium iodine, commercially availablefrom 3M Company). The tube included threads on the spout complementaryto those provided on the stem. The tube was heat sealed usingconventional methods.

[0075] The sealed tube of surgical prep solution was opened by removingthe cap, and for the case where an induction sealed foil covers theopening, the foil seal was perforated, and the tube of surgical prepsolution was attached to the spreader element connector by the threadingthe spout into the threads in the stem. The container element wasgripped in the manner of a handle, and the applicator was used to spreadthe surgical prep solution onto the torso of a patient. A smooth, evenapplication was achieved without dripping.

Example 2

[0076] About 21 g of DURAPREP Surgical Solution (a hydroalcoholicsolution containing 74% w/w isopropyl alcohol and 0.7% available iodine)was filled into 1 oz. Expac poly film/foil/polyfilm laminate tubesavailable from Expac Corp. of Hopkins, Minn., as model number 5485X. Theexact weight of the tube before and after filling was recorded to 4decimal places. The tubes were heat sealed. Two sets of 10 tubes wereprepared. Set A had a foil seal welded over the tip. Set B did not. Bothsets of tubes had a polycap screwed on tightly over the tip. The tubeswere placed in a recirculated oven at 50° C. for 28 days. The tubes wereremoved periodically and weighed. The weight was recorded to fourdecimal places. The following results were obtained: % Weight Loss AfterAging At 50° C. Set A Set B Day Mean Mean 0 0 0 3 0.0332 0.0419 7 0.04080.0577 10 0.0503 0.0651 14 0.0534 0.0782 17 0.0571 0.0838 21 0.06890.0906 24 0.0761 0.1058 28 0.09 0.1155

[0077] The data indicates that even after 28 days at 50° C. the meanvalue of the Set A samples with the foil seal was only 0.0900% while theset without the seal was only 0.1155%. This proves that this poly/foilconstruction is an exceptional barrier to water and alcohol even underexaggerated conditions.

Example 3

[0078] The same tube construction used in Ex. 2 was filled with 26 gwater. Ten tubes were sealed and capped without the foil cap seal. Thetubes were ETO sterilized in a 3M Sterivac Model 4 XL ethylene oxidesterilizer. The tubes were then aerated for one hour twenty minutes in a3M model XL Aeratra cabinet. This results in an exposure to ethyleneoxide gas for about four hours and ten minutes at 500 millibars and anaeration time of one hour and twenty minutes. The samples were sent toBiotest Labs in Minneapolis, Minn., for testing. The contents of thetubes by gas chromatography for residue of ethylene oxide, ethylenechlorohydrin and ethylene glycol. The presence of these compounds in thecontents of the tubes would indicate that the tube allowed some of theethylene oxide sterilant to enter the tube during the sterilizationcycle.

Results

[0079] All of the containers were found to have non-detectable levels ofethylene chlorohydrin and ethylene glycol. Six of the ten Expaccontainers were evaluated to have non-detectable levels of ethyleneoxide. Four of the ten Expac containers were evaluated to have 1part-per-million (ppm) of ethylene oxide, corresponding to 0.021 mg ofethylene oxide per 26 ml of tap water. The detection limit of the gaschromatograph used to complete the analysis is 1 ppm.

[0080] The reference document under which the test was conducted wasANSI/AAMI/ISO 10993-7 BIOLOGICAL EVALUATION OF MEDICAL DEVICES- PART 7:ETHYLENE OXIDE STERILIZATION AND ANSI /AAMI ST30: DETERMINING RESIDUALETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES. Thecontainers appear to provide an effective barrier to ethylene oxidesterilization.

[0081] All references and publications cited herein are expresslyincorporated herein by reference in their entirety into this disclosure.Illustrative embodiments of this invention are discussed and referencehas been made to possible variations within the scope of this invention.These and other variations and modifications in the invention will beapparent to those skilled in the art without departing from the scope ofthis invention, and it should be understood that this invention is notlimited to the illustrative embodiments set forth herein. Accordingly,the invention is to be limited only by the claims provided below.

What is claimed is:
 1. An applicator system for surgical prep solution, the system comprising: a spreader element comprising: a body comprising an orifice; a pad attached to the body over the orifice; a stem comprising a distal end attached to the body and a passage extending between the distal end of the stem and a proximal end of the stem, wherein the passage is in fluid communication with the orifice at the distal end of the stem; a collapsible container comprising: surgical prep solution; a spout adapted to attach to the proximal end of the stem, wherein the surgical prep solution can be delivered to the passage for delivery to the pad; wherein the collapsible container comprises an original volume and a collapsed volume after dispensing of the surgical prep solution, and further wherein the collapsible container recovers about 50% or less of a difference between the original volume and the collapsed volume within 30 seconds of dispensing a majority of the surgical prep solution.
 2. The system of claim 1 , wherein the collapsible container recovers about 25% or less of a difference between the original volume and the collapsed volume within 30 seconds of dispensing a majority of the surgical prep solution.
 3. The system of claim 1 , wherein the surgical prep solution comprises iodine or chlorhexidine.
 4. The system of claim 3 , wherein the collapsible container is substantially impermeable to ethylene oxide gas.
 5. The system of claim 1 , wherein the spreader element further comprises a pad seal between the pad and the body.
 6. The system of claim 5 , wherein the pad seal comprises a weld such that the pad is welded to the body.
 7. The system of claim 1 , wherein the spout comprises a container seal, and further wherein the spreader element comprises a piercing element adapted to open the container seal when the spout is attached to the stem.
 8. The system of claim 7 , wherein the piercing element comprises an annular die.
 9. The system of claim 1 , further comprising a flow restrictor.
 10. The system of claim 9 , wherein the flow restrictor comprises the passage, and further wherein the passage comprises a ratio of length of the passage between the distal and proximal ends to a minimum cross-sectional dimension of the passage of about 20:1 or more.
 11. The system of claim 9 , wherein the flow restrictor comprises the orifice.
 12. The system of claim 1 , wherein the spreader element and the container comprise sterile exterior surfaces.
 13. A method of applying surgical prep solution, the method comprising: providing a spreader element comprising a body comprising an orifice; a pad attached to the body over the orifice, a stem comprising a distal end attached to the body and a passage extending between the distal end of the stem and a proximal end of the stem, wherein the passage is in fluid communication with the orifice at the distal end of the stem; providing surgical prep solution in a collapsible container; attaching the collapsible container to the proximal end of the stem, wherein the surgical prep solution is in fluid communication with the passage of the stem; and dispensing the surgical prep solution into the passage by compressing the collapsible container, wherein the collapsible container comprises an original volume and a collapsed volume after dispensing of the surgical prep solution, and further wherein the collapsible container recovers about 50% or less of a difference between the original volume and the collapsed volume within 30 seconds of dispensing a majority of the surgical prep solution.
 14. The method of claim 13 , wherein the spout comprises a container seal and the spreader element comprises a piercing element, and further wherein attaching the spout to the stem comprises piercing the container seal with the piercing element.
 15. The method of claim 13 , further comprising sterilizing the spreader element and the collapsible container before attaching the spout to the stem.
 16. The method of claim 13 , wherein the surgical prep solution comprises iodine or chlorhexidine, and further wherein the collapsible container is substantially impermeable to ethylene oxide gas before the dispensing.
 17. The method of claim 13 , wherein the spreader element further comprises a pad seal between the pad and the body.
 18. The method of claim 17 , wherein providing the spreader element comprises welding the pad to the body to form the pad seal.
 19. A method of manufacturing an applicator system for surgical prep solution, the method comprising: providing a spreader element comprising a body comprising an orifice; a pad attached to the body over the orifice; a stem comprising a distal end attached to the body and a passage extending between the distal end of the stem and a proximal end of the stem, wherein the passage is in fluid communication with the orifice at the distal end of the stem; providing a collapsible container comprising surgical prep solution and a spout adapted to attach to the stem of the spreader element, wherein the surgical prep solution can be delivered to the passage for delivery to the pad; wherein the collapsible container comprises an original volume and a collapsed volume after dispensing of the surgical prep solution, and further wherein the collapsible container spontaneously recovers about 50% or less of a difference between the original volume and the collapsed volume within 30 seconds of dispensing a majority of the surgical prep solution.
 20. The method of claim 19 , further comprising sterilizing the spreader element and exterior surfaces of the collapsible container.
 21. The method of claim 19 , wherein the surgical prep solution comprises iodine or chlorhexidine, and further wherein the collapsible container is substantially impermeable to ethylene oxide gas.
 22. The method of claim 19 , wherein the spreader element further comprises a pad seal between the pad and the body.
 23. The method of claim 22 , wherein providing the spreader element comprises welding the pad to the body to form the pad seal.
 24. An applicator system for surgical prep solution, the system comprising: a spreader element comprising: a body comprising an orifice; a pad attached to the body over the orifice; a stem comprising a distal end attached to the body and a passage extending between the distal end of the stem and a proximal end of the stem, wherein the passage is in fluid communication with the orifice at the distal end of the stem; a collapsible container attached to the proximal end of the stem, the collapsible container retaining surgical prep solution therein; wherein the collapsible container comprises an original volume and a collapsed volume after dispensing of the surgical prep solution, and further wherein the collapsible container recovers about 50% or less of a difference between the original volume and the collapsed volume within 30 seconds of dispensing a majority of the surgical prep solution.
 25. The system of claim 24 , wherein the container comprises a container seal retaining the surgical prep solution within the collapsible container.
 26. An applicator system for surgical prep solution, the system comprising: a container retaining surgical prep solution therein; and a spreader element comprising: a body comprising an orifice; a pad attached to the body over the orifice; a stem comprising a distal end attached to the body and a passage extending between the distal end of the stem and a proximal end of the stem, wherein the passage is in fluid communication with the orifice at the distal end of the stem; and a receptacle at the proximal end of the stem, the receptacle extending around at least a portion of a circumference of the container when the container is attached to the spreader element.
 27. The system of claim 26 , wherein the receptacle extends around only a portion of the circumference of the container when the container is attached to the spreader element.
 28. The system of claim 26 , wherein the container comprises a collapsible container, and further wherein the collapsible container comprises an original volume and a collapsed volume after dispensing of the surgical prep solution, and further wherein the collapsible container recovers about 50% or less of a difference between the original volume and the collapsed volume within 30 seconds of dispensing a majority of the surgical prep solution. 